Second Primary Lung Cancer Cohort Study (SPORT)

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT04178889
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

Brief Summary

Patients who have had curative treatment for lung cancer are at an increased risk of developing second primary lung cancers (and other cancers) over the next 10 years. Doctors need to develop better ways of monitoring patients during follow up so we can intervene as quickly as possible with further treatments. Measuring DNA in the blood which has come from the tumour, so called circulating tumour DNA (ctDNA), may be one way to do this.

Detailed Description

This is a multi-centre, observational basic science study to follow patient who have undergone radical treatment, surgery or radiotherapy for Non-small Cell Lung Cancer (NSCLC) between two and five years previously. Following consent, participants will be asked to provide blood samples every six months for up to the next five years. Information from their routine clinical care, including information from any imaging, diagnostic tissue samples and blood tests will be collected. We will also request access to any original surplus diagnostic material, as well as future, excess tissue from diagnostic samples.

Blood samples will be analysed using various new scientific techniques looking to correlate emergence of new primary cancer (or recurrence of original NSCLC) with blood based markers.

Study Timeline

• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Study Start: 2020-01-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

• previous treatment with curative intent (surgery or radical (chemo)radiotherapy) for stage I-IIIA primary NSCLC
• at least two years post first treatment date of first primary NSCLC
• able to provide informed consent

Exclusion Criteria

• Primary lung tumour was a carcinoid tumour
• in the opinion of the managing clinician, thought unlikely to survive 12 months from time of potential recruitment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment of 850 patients who have undergone treatment with curative intent for stage 1 - 3A non-small cell lung cancer.	5 years	In order to: collect baseline demographics, clinical and past medical history to obtain blood samples every 6 months after recruitment; to collect relevant imaging and clinical data as part of their on-going routine clinical care

Secondary Outcome Measures

Name	Time	Method
To collect blood samples from the cohort of patients.	From recruitment through to end of study (or 5 year follow up point, whichever comes first)	Have the blood samples been collected at follow up visits.
To collect surplus diagnostic tissue from the cohort of patients.	Identify original diagnostic sample at recruitment.	To collect surplus diagnostic tissue from original non-small cell lung cancer.
To collect surplus diagnostic tissue from new cancer occurrences or relapse from the cohort of patients	From recruitment to end of study (or 5 year follow up point, whichever comes first)	Collection of surplus diagnostic tissue if any second primary cancer or recurrence occurs.

Trial Locations

Locations (1)

Royal Papworth Hospital; 🇬🇧 Cambridge, United Kingdom